Perspective: Information, Inspiration and Advocacy for People Living with HIV/AIDS

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gesting that the more intact the immune
system the better the benefit of this approach. The study is enrolling people with
CD4+ counts of greater than 300, who have
willing HIV-negative family members with
suitable cell types. While seemingly "high
tech", most such studies are relatively easy
to participate in. Both having the cells
drawn, and having them infused, is similar
to giving blood, and takes just a few hours.
IL-1 2 Study Enrolling!
A study to find the best dose for IL-12 is
enrolling across the country. The first phase
is open to people with CD4+ cell counts of
less than 50. Later phases will be open to
people with counts between 300 and 500.
IL-12 may enhance macrophage function.
These cells fight many of the infections associated with HIV-disease, particularly Mycobacterium avium Complex (MAC). Thus,
IL-12 may be useful in preventing these infections. It may also be important in enhancing other types of immune function.
IL-12 or a placebo will be given by an injection under the skin twice weekly for 4
weeks. Volunteers will be allowed to use
anti-HIV therapy and will be required to
be on preventative therapy for PCP. The
goal is to find an optimal dose for use in
larger trials, and volunteers will receive IL12 doses of 30, 100 or 300 ng/kg (nanograms per kilogram of body weight), or
placebo. The 30 ng/kg dose group has fully
enrolled and new volunteers will receive the
100 ng/kg or 300 ng/kg dose, or placebo.
For study locations, call 800-TRIALS-A and
ask for information about ACTG 325.
WF-1O Studies
WE-lO, a product of Oxie-Chemie (Germany), has showntinteresting immunologic
properties in a small study at San Francisco
General Hospital. Earlier studies of the
drug, which lacked adequate controls, suggested the drug may enhance protection
against infections in people with advanced
HIV disease. In this study, WF-10 appeared
to provide a significant and substantial enhancement of macrophage function and
activity, which might lead to better response
against opportunistic infections. It also appeared to do this without stimulating T-cell
activation or increasing viral load, two concerns which the FDA had raised earlier.
Although how the drug does this is somewhat uncertain, these results suggest it may
be a potent yet very selective activator of
macrophages. If a planned additional study
shows clinical benefit to this activity, WF10 may find its place among immune-based
therapies. It is sold in Germany and other
countries to hasten healing of wounds. U

Expanded Access
Programs Expanding
Three new drugs are currently available in expanded access programs - abacavir (formerly known as GW1592), adefovir
(Preveon@, formerly known as bis-POM PMEA and GS 840)
and efavirenz (Sustiva@, formerly known as DMP-266).

Although initial programs for these drugs
are very small and constrained by limited
drug supplies, they will soon be expanded
to provide access to a wider group of
people. The first step of expanding the
efavirenz program is likely to be announced
by the time readers receive this issue of PI
Perspective, and a final form of the program should be in place early in 1998. Expansion of the program for abacavir should
also take place early in 1998.
Efalvirenz
This drug is a highly potent non-nucleoside
analogue reverse transcriptase inhibitor
(NNRTI), the same class of drug as
nevirapine (Viramune@) and delavirdine
(Rescriptor@). Although only preliminary
information is available, the drug has shown
fairly remarkable activity when used in
combination with indinavir (Crixivan@).
Additional clinical trials are studying its use
in combination with a wide variety of other
drugs, including AZT + 3TC, other protease inhibitors, and combinations employing one each of all three classes of drugs.
Perhaps the most remarkable quality of
efavirenz is that it remains stable in the body
longer than almost any other currently
available AIDS therapy. This quality permits the simplicity of once-daily dosing.
The initial efavirenz program was limited
to people with fewer than 50 CD4+ cells
with a history of failure on current regimens. The first stage expansion of the program extends the CD4+ cell limit to 200.
The final stage of the program, if agreed to
by the Food and Drug Administration, will
eliminate CD4+ cell limits. For more on the
efavirenz program call 800-998-6854.
Albacavir
This widely discussed drug, formerly known
as GW1592, is a highly potent nucleoside
analogue. It's highest level of potency, however, is limited to people who have not previously used other drugs of this class. New
data shows that in general, the more drugs
of this type a person has previously used to
the point of failure, the less likely it is that
this drug will work. Thus, its role will be
limited, even though it is likely to make an
excellent choice for first time therapy.

The current program for abacavir is limited to people who have CD4+ cell counts
below 100, a viral load above 30,000 cop-. ies HIV RNA and who have failed at least
one protease inhibitor regimen. The expansion of this program in early 1998 should
at the very least remove these restrictions
and make the drug widely available to
people who need it to build an effective
combination. For information on the program call 800-501-4672.
SAdefovir
This is a nucleotide analogue which blocks
HIV replication at the same stage of the
virus life cycle as the nucleoside analogues
and is dosed once daily. Results from earSlier studies show modest anti-HIV activity
when used alone. It is not known how well
people who have failed on existing nucleoside analogue therapy will respond to
adefovir. This drug also has activity against
* hepatitis B virus and cytomegalovirus
(CMV) - however it is unlikely that adefovir
can be used to treat CMV, although it may
* be effective in preventing the disease.
The current program is limited to those who
have CD4+ cell counts below 50, a viral
load above 30,000 copies HIV RNA and
who have failed or are intolerant to a com*bination regimen containing two nucleoside
analogues and a protease inhibitor. For
more on the program call 800-445-3235.
SRedefining. Expanded Access
All previous expanded access programs for
new drugs have been a product of the older
era of AIDS therapy, which supplied one
new drug at a time when earlier therapies
failed. Today, we know that this model is
ineffective and even harmful in the sense. that it wastes the opportunity to truly benefit from the new drugs. But the same old
rules continue to make the new drugs available in this fashion. This year, many treatment activists, as well the some of the manufacturers, are attempting to redefine the
rules of expanded access to reflect the cur-. rent recommendations for treating HIV dis* ease. The key rules of current therapy call
for avoiding the use of single drug therapy,

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PI PERSPECTIVE NUIVBER 23 NOVEIVBER 1 997